Setting specifications for related impurities in antibiotics

This guideline applies to human and veterinary medicines.

Current effective version

PDF iconAdopted guideline

Reference number CHMP/CVMP/QWP/199250
Published 13/07/2012
Effective from 30/06/2013
Keywords Antibiotics, specifications, related impurities
Description This document provides guidance for marketing authorisation applications on setting specifications for related impurities in antibiotics. It applies to antibacterial substances that are fermentation products or semisynthetic substances derived from fermentation products.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 30/06/2013–present


Published: 13/07/2012


Published: 30/07/2010


Published: 09/07/2008

Related content for human medicines

Related content for veterinary medicines

How useful was this page?

Add your rating